Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABVC, Astellas, Aum, Biocryst, Curis, Genfleet, Junshi, Novavax, Oncopeptides, Otsuka.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arrowhead, Cybin, Enlivex, GSK, Novavax, Omeros, Organon, Otsuka, Redhill, Samsumg, SK.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Proteome, Atomwise, Bristol Myers Squibb,Codagenix, Defence, Endo, Ibio, Innocan, Sanofi, Scilex, Turning Point.
Staidson Biopharmaceuticals Co. Ltd. is testing a combination of two monoclonal antibodies (MAb), STSA-1002 and STSA-1005, in China for the potential treatment of people with severe-to-critical COVID-19.
A study involving more than 1.25 million people in the U.S. has shown there is an increased risk of developing certain neurological and psychiatric conditions for up to two years after COVID-19 infection, and that despite causing less serious disease in the acute phase, the risk with omicron is the same as with the delta variant of SARS-CoV-2.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agios, Antengene, Aptinyx, Gannex, Greenwich, Mersana, Newamsterdam, Palatin, Pfizer, Pneumagen, Revive, Unity, Ventyx.
Moderna Inc. has received conditional authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency for its bivalent COVID-19 booster vaccine mRNA-1273.214 (Spikevax bivalent original/omicron). The conditional approval, which covers adults aged 18 years and older, marks a new phase in the ongoing global effort to curb the COVID-19 pandemic, as the new vaccine represents the first commercial product to incorporate omicron-specific epitopes. It contains 25 micrograms each of the spike proteins of the omicron BA.1 variant and the original Wuhan strain of SARS-CoV-2.
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